Patient Medication Information: uses, side effects, how to take - Givlaari
What GIVLAARI is used for:
GIVLAARI is used to treat acute hepatic porphyria (AHP) in adults. AHP is a rare illness that runs in families.
How GIVLAARI works:
Acute hepatic porphyria is caused by a defect in one of the proteins that make a molecule called heme in the liver. This results in a build-up of some of the substances that are used to produce heme, namely aminolevulinic acid (ALA) and porphobilinogen (PBG). Having too much ALA and PBG can injure nerves and cause serious attacks of pain, nausea, muscle weakness and changes in mental functioning. Some people with AHP may also have symptoms, such as pain and nausea, in between attacks.
GIVLAARI works by lowering the amount of an enzyme, called ALAS1. This enzyme controls how much ALA and PBG are made by the liver. By lowering ALAS1, the liver makes less ALA and PBG. This can help to reduce the symptoms of this illness.
The ingredients in GIVLAARI are:
Medicinal ingredient: givosiran (as givosiran sodium)
Non-medicinal ingredients: phosphoric acid and/or sodium hydroxide (as needed), water for injection
GIVLAARI comes in the following dosage form:
Solution: 189 mg / mL
Do not use GIVLAARI if:
- you have ever had a severe allergic reaction to givosiran, or any of the other ingredients of this medicine. If you are not sure, talk to your healthcare professional before you are given GIVLAARI.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take GIVLAARI. Talk about any health conditions or problems you may have, including if you:
- have or have had liver problems.
- have or have had kidney problems or are on dialysis.
are pregnant, think you might be pregnant, or are planning on becoming pregnant.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
GIVLAARI may cause serious side effects, including:
Liver problems:
- Using GIVLAARI can affect your liver.
- You will have blood tests to check your liver function before you start treatment with GIVLAARI and periodically during treatment. If these tests show abnormal results, your healthcare professional will decide whether to interrupt treatment or stop treatment permanently.
- Abnormal results have been seen in some patients treated with this medicine, typically between 3 to 5 months after starting treatment.
Kidney problems:
- Using GIVLAARI can affect your kidneys, especially if you have already been diagnosed with kidney problems.
- Your healthcare professional will check how your kidneys are working periodically during treatment.
Serious allergic reaction:
- Serious allergic reactions may happen in people taking GIVLAARI. This may affect many different body systems.
- Your healthcare professional will monitor you for signs and symptoms of a serious allergic reaction.
- If you have a serious allergic reaction, your healthcare professional will stop your GIVLAARI treatment. You may need to take other medicines to manage the reaction.
Hyperhomocysteinemia (high homocysteine levels in the blood):
- GIVLAARI may cause your homocysteine levels in your blood to be high. Homocysteine is a type of amino acid that is normally found in your body.
- Your healthcare professional will check the levels of homocysteine and other vitamins in your blood before you start treatment. The levels of homocysteine in your blood will be measured again during your treatment.
- If your homocysteine levels are higher than normal, your healthcare professional may need to do other blood tests. They may recommend that you start taking vitamins or other medications.
See the Serious side effects and what to do about them table, below, for information on these and other serious side effects.
Female patients
Pregnancy
- If you are pregnant, think you might be pregnant, or are planning on becoming pregnant, talk to your healthcare professional.
- It is not known if GIVLAARI will harm your unborn baby.
- If you become pregnant while receiving treatment, tell your healthcare professional right away.
Breast-feeding
- GIVLAARI may pass into the breast milk. It is not known how it will affect the baby.
Talk to your healthcare professional about alternative ways to feed your baby during
- treatment with GIVLAARI. You and your healthcare professional should decide if the benefit of breastfeeding is greater than the risk to your baby.
- Blood tests and monitoring:
- GIVLAARI can cause abnormal blood test results.
- Your healthcare professional will perform blood tests while you are taking GIVLAARI to check the health of your liver and kidneys and your homocysteine levels. They will decide when to perform blood tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with GIVLAARI:
- Medicines used to treat depression, such as venlafaxine, duloxetine
- Metoprolol, medicine used to lower blood pressure
- Perphenazine, medicine used to treat schizophrenia
- Theophylline, medicine used to treat breathing problems like asthma and COPD
- Tizanidine, a muscle relaxant
- Tolterodine, medicine used to treat overactive bladder
- Tramadol, medicine used to treat severe pain
- Cold medicines containing dextromethorphan
- Supplements (such as caffeine)
How to take GIVLAARI:
- GIVLAARI will be given to you by a healthcare professional.
- GIVLAARI is given as an injection under the skin. This is called a “subcutaneous injection”. It will be given in your stomach area (abdomen), or some cases, in your upper arm or thigh. The site of the injection will be rotated.
- If the dose is more than 1 mL, more than one vial will need to be used and more than one subcutaneous injection may need to be given.
Usual dose:
- Your healthcare professional will decide how much GIVLAARI to give you. The amount will depend on your body weight.
- You will be given GIVLAARI once a month (every 4 weeks).
- If blood tests show problems with your liver, your healthcare professional may interrupt GIVLAARI treatment or stop treatment permanently. Your healthcare professional may consider starting again at a lower dose.
Overdose:
| If you think you, or a person you are caring for, have been given too much GIVLAARI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Missed dose:
If you have missed an appointment for your injection, talk to your healthcare professional as soon as possible.
Possible side effects from using GIVLAARI:
These are not all the possible side effects you may have when taking GIVLAARI. If you experience any side effects not listed here, tell your healthcare professional.
- Nausea
- Injection site reaction (redness, pain, itching, or swelling)
- Red, itchy or dry skin, eczema or hives (skin rashes)
- Feeling tired (fatigue)
- A mild to moderate type of allergic reaction – with symptoms such as hives, rash, itching, swelling of eyes, mouth or face.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Only if severe | In all cases | |||||
| Very common | ||||||
| Liver problems: abdominal pain, nausea, vomiting, abdominal distension, yellowing of the skin and whites of the eyes, unusual tiredness, loss of appetite, dark urine and pale stool, abnormal liver blood tests. | ✓ | |||||
| Kidney problems: nausea, vomiting, fatigue, confusion, swelling of the extremities, increased or decreased urine output, blood in the urine, abnormal kidney blood tests. | ✓ | |||||
| Common | ||||||
| Hyperhomocysteinemia (high levels of homocysteine in the blood): pale skin, weakness, dizziness, fatigue, tingling in arms, hands or feet, mouth sores. | ✓ | |||||
| Uncommon | ||||||
| Serious allergic reaction (affecting multiple body systems): swelling of the lips, tongue or throat, difficulty swallowing or breathing, wheezing, feeling dizzy or fainting, nausea or vomiting, rash or hives, itching. | ✓ | |||||
| Unknown | ||||||
| Pancreatitis (inflammation of the pancreas): nausea, vomiting, fever, fast heartbeat, strong pain in the upper belly that does not go away and may feel very sore when touched. The pain may spread to your back and feel worse after eating. | ✓ | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store GIVLAARI at 2°C to 25°C.
- Keep GIVLAARI vial in the original carton to protect from light until ready for use.
- Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
- Keep out of reach and sight of children.
- Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.
If you want more information about GIVLAARI:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://www.alnylam.ca/givlaari-monograph-en ; https://www.alnylam.ca/givlaari-monograph-fr); or by calling 1-877-256-9526.
Date of Authorization: 2026-08-07